Job Details

Position Summary

We are seeking an accomplished and strategic Vice President, Clinical Regulatory Affairs to lead the design and execution of global regulatory strategies for our expanding our trusted immuno-modulatory platform into new indications. This leader will bring deep experience navigating complex regulatory environments across FDA, EMA, and ideally PMDA, with a proven ability to secure expedited approvals through innovative pathways.

The ideal candidate combines strategic vision with a hands-on, can-do mindset, thrives in a fast-paced biotech environment, and is passionate about bringing transformative therapies-particularly in immunological disorders, cell therapy, and oncology-to patients faster.

Key Responsibilities

Regulatory Strategy & Leadership
• Define and lead global regulatory strategies across all development stages.
• Serve as a key strategic advisor to executive leadership on regulatory opportunities and risks impacting clinical development and corporate goals.
• Anticipate and shape regulatory trends to enable innovative approaches to development, approval, and market access.

Regulatory Agency Engagement
• Lead interactions and negotiations with FDA, EMA, and other health authorities to secure alignment on development plans and registration pathways.
• Represent the company at major regulatory meetings, delivering clear and authoritative clinical and regulatory rationale.
• Build and maintain trusted relationships with regulators, advisors, and key external stakeholders.

Innovative Development Pathways
• Design and implement successful regulatory strategies that enable Clinical Development programs to excel by leveraging expedited pathways (e.g., Breakthrough Therapy, PRIME, RMAT, Accelerated Approval).
• Partner cross-functionally to align regulatory strategy with innovative trial designs, biomarker, and -omics approaches.
• Drive creative, risk-based solutions to accelerate time to approval while maintaining scientific and ethical integrity.

Leadership & Cross-Functional Collaboration
• Build, lead and mentor a high-performing regulatory team with a culture of accountability, innovation, and excellence.
• Collaborate closely with Clinical Development, Medical Affairs, CMC, Clinical Operations, HEOR, and Pharmacovigilance to ensure integrated development and submission strategies.
• Contribute to portfolio prioritization and overall corporate strategy as a senior member of the Development leadership team.

Qualifications & Experience
• Education: Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, or equivalent).
• Experience:

o Minimum 15-20 years in regulatory affairs, including leadership roles in global pharma or biotech.

o Demonstrated success designing and defending regulatory strategies with FDA and EMA; PMDA experience is highly desirable.

o Proven track record of achieving expedited regulatory approvals (Breakthrough, fast track, PRIME, RMAT, etc.).

o Prior experience in immunology, cell therapy, or oncology is strongly preferred.
• Leadership:

o Strategic thinker with the ability to influence at all levels of the organization.

o Exceptional communicator who can simplify complex clinical regulatory issues for diverse audiences.

o Resilient, proactive, and collaborative-able to thrive in a fast-moving, entrepreneurial biotech-like culture.

What We Offer
• A leadership opportunity to shape the regulatory vision for a rapidly moving organization.
• The chance to work on transformative therapies at the cutting edge of immuno-modulation.
• Dynamic, collaborative culture with competitive compensation, equity participation, and global career growth opportunities.